Bryan 1996.
Methods | DESIGN: Single centre RCT (university). LENGTH OF FOLLOW‐UP: 6 weeks and 6 months after intervention (all outcomes). DATA ANALYSIS: Unclear. Not explicitly stated but sample sizes for outcome assessments (given in Table 3) suggest analysis was based on intervention received (i.e. excluding attrition). ATTRITION RATE: Attrition at 6‐week and 6‐month follow up interviews: Group 1: Condom promotion group; 6 weeks: 21%; 6 months 27%. Group 2: Stress management control group: 6 weeks 23%; 6 months 27%. UNIT OF DATA ANALYSIS: Individuals SAMPLE SIZE CALCULATION: No information provided EQUIVALENT STUDY GROUPS AT BASELINE: The groups were similar in terms of age, ethnicity, % having had intercourse, age at first intercourse, number of sexual partners, % who used condoms all the time and % who used other birth control all the time. The groups thus appear to be equivalent. Authors stated that no differences were found between conditions at pretest. Note however that no socio‐economic information was reported. PROCESS EVALUATION: A process evaluator monitored each experimental programme presentation and noted on a checklist which of 37 (unspecified) points of the programme was mentioned. The authors stated that the condom use intervention was implemented with high accuracy, with each of the 37 critical points delivered in all presentations. In every session all women participated in the condom use practical exercises. No other details of process evaluation were provided. |
|
Participants | NUMBER RANDOMISED: 198 AGE (years): Mean (SD): Group 1: 18.63 (1.23); Group 2: 18.63 (1.42). GENDER: All female (unmarried undergraduate students). SOCIO‐ECONOMIC STATUS: Not stated. ETHINCITY/RACE: 79% Caucasian; 8% Hispanic; 5% Asian American; 4% native American; 3% African American; 1% other. LOCATION: USA; region not stated (location reported only as a large south western university). PREVIOUS STI: 7% of all the women reported ever having had an STI. SEXUAL RISK BEHAVIOUR: Unmarried female undergraduate students of which 76% were sexually active (had had intercourse at least once) (Group 1: 72%; Group 2: 81%). Mean duration of sexual activity: 2.4 years. Mean (SD) age (years) at first intercourse: Group 1: 16.11 (1.13); Group 2: 16.31 (1.55). Of this sexually active group only 16% reported using condoms 100% of the time and 73% had had more than one partner in their lifetime. |
|
Interventions | NAME OF STUDTY: Not stated GROUP 1: Education and skills development intervention: condom promotion and use (n = 100) YEAR STARTED: Not reported. PROVIDER(S): Researcher (female graduate student plus an assistant) SETTING: Education (university, undergraduate population) TYPE: Information/Education; Practical skill (stress management; the ability to discuss condom use with sexual partners; modelling correct condom use). DURATION: One 45‐minute session. THEORETICAL BASIS: Health Belief Model; Traditional Education. Bryan et al. (1997) also mention the Theory of Reasoned Action as background to the intervention, though Bryan et al. (1996) did not refer to this. STIs COVERED: STIs in general; none specifically mentioned. GROUP 2: Education and skills development control: stress management (n = 98) This was comparable in format to the experimental programme, including an interactive format between presenter and audience and group participation in stress‐reducing exercises. |
|
Outcomes | PRIMARY: No outcomes were explicitly nominated as primary and no statistical power calculations were reported. SECONDARY: Attitudes (affective attitudes towards condoms) Awareness/Beliefs (perceived susceptibility to STIs; perceived severity of STIs; perceived benefits of using condoms; control over the sexual encounter) Behaviour: recorded for all participants (has purchased condoms; has carried condoms; has practiced telling partners to use condoms; has discussed condom use with partner); recorded for sexually active participants (has used condom at last intercourse) Intentions (to buy, carry, practice discussing, discuss with a partner or use condoms) Self‐efficacy/self‐esteem/self‐confidence (condom use self‐efficacy) |
|
Notes | COST DATA: None reported. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | No information provided; stated only that the design was a randomised experiment. |
Allocation concealment? | Unclear risk | No information provided. |
Blinding? All outcomes | Low risk | The research assistants who conducted the follow‐up telephone interviews were unaware of the experimental group. |
Incomplete outcome data addressed? All outcomes | Unclear risk | The proportion of data missing was similar for the experimental and control groups but no reasons for the missing data were provided. |
Free of selective reporting? | Unclear risk | The paper lacks a clear a priori statement of all measured outcomes. The five listed behavioural outcomes were mentioned briefly at the end of the methods section and also reported on in the results section. Other outcomes were introduced at the same time as their results were presented (e.g. in Fig. 2), which makes a judgement of selective reporting difficult. |
Free of other bias? | Unclear risk | Although the trial groups were equivalent at baseline in terms of sexual behaviour and demographic characteristics, it is unclear whether they were equivalent in terms of socio‐economic status. |